Clinical and Medical Affairs in Medical-device Development

The clinical and medical-affairs role

Clinical and Medical Affairs supplies the professional judgement needed to understand the disease or condition, current practice, users, patients, benefits, harms and evidence. The function should shape development from product definition onwards, not arrive at the end to write a clinical report around decisions already made.

Define the clinical need before the product claim

Describe the condition, patient population, care pathway, current alternatives, intended users, use environments and the problem the device is meant to address. Distinguish a genuine clinical benefit from convenience, technical performance or a commercial preference. Identify vulnerable populations, inequalities, contraindications and situations in which use could cause delay or inappropriate treatment.

Keep this work aligned with MTL-102 — Intended Purpose, Users and Use Environments.

Turn product claims into answerable evidence questions

For each proposed indication, benefit or performance claim, state the population, intervention or device, comparator where relevant, outcome, time horizon and use context. Define what result would support the claim and what uncertainty would remain. Marketing language, labelling and study endpoints must describe the same product and clinical proposition.

Build a proportionate evidence strategy

• Map every material claim and safety question to an evidence source.
• Separate scientific validity, analytical performance and clinical performance for IVDs.
• Distinguish device-specific data from state-of-the-art or equivalent-product evidence.
• Define evidence quality, relevance and acceptance criteria before collection.
• Identify gaps, assumptions, bias and uncertainty explicitly.
• Align study timing with design maturity and regulatory decisions.
• Plan PMCF, PMPF or other post-market evidence for residual questions.

Use MTL-119 — Clinical and Performance Evaluation for the wider evidence framework.

Appraise evidence; do not merely collect it

Use a documented search and appraisal method. Assess relevance to the intended product, population, user, setting, comparator and outcome; examine study design, bias, confounding, statistical precision and consistency. Include unfavourable and inconclusive evidence. A large bibliography does not compensate for evidence that is indirect or methodologically weak.

Make investigations ethical, necessary and decision-led

Define the question, endpoint, population, comparator, sample rationale, analysis and decision before collecting data. Use a sufficiently controlled and representative device configuration. Protect participants, informed consent, privacy and data integrity; manage investigators, sites, deviations, adverse events and device deficiencies. Preserve the protocol, statistical plan, dataset, analysis and report as one traceable evidence package.

Connect benefit and clinical harm to risk management

Clinical expertise helps translate failure, misuse, incorrect results and treatment delay into credible consequences. Review severity assumptions, affected populations, contraindications, foreseeable clinical sequences and benefit-risk conclusions. New clinical evidence must be assessed for impact on hazards, risk controls, residual risk, labelling and post-market actions.

Work with MTL-114 — Medical-device Risk Management.

Keep clinical communication inside the evidence boundary

Review intended purpose, indications, contraindications, warnings, performance statements, training, promotional material and responses to clinical enquiries. State limitations and uncertainty clearly. Medical Affairs should enable accurate scientific exchange without creating unsupported claims or an uncontrolled alternative to approved labelling.

Maintain the clinical position after release

Review complaints, vigilance, literature, registries, real-world data, user feedback and changes in clinical practice. Compare emerging evidence with the original assumptions and known residual risks. Trigger controlled updates to the evaluation, risk file, labelling, studies and regulatory strategy when the benefit-risk position or state of the art changes.

Connect this work to MTL-326 — EU Post-market Surveillance, PMCF / PMPF and PSUR Guidance.

Common misconceptions